Frailty Clinical Trial
Official title:
Cognitive Prefrail and Frailty, and Motoric Cognitive Risk Syndrome: Prevalence and Association With Incident Adverse Health Events in the Canadian Longitudinal Study on Aging
Verified date | April 2024 |
Source | Jewish General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
We defined a new and early condition in the spectrum of cognitive frailty: the "cognitive-prefrailty" which is a combination of prefrailty stage and subjective cognitive impairment (SCI). This study aims to: (1) examine and compare the prevalence of cognitive-prefrailty, cognitive frailty and motoric cognitive risk syndrome (MCR) syndromes in participants of the Canadian Longitudinal Study of Aging (CLSA) using the (tracking and comprehensive) baseline assessment, (2) examine the association of cognitive-prefrailty, cognitive frailty and MCR syndromes with incident adverse health events using the information collected during the first CLSA 18-month follow-up, and (3) compare the criteria performances (i.e., sensitivity, specificity, positive predictive value, negative predictive value, area under receiver operating characteristic curve, positive and negative likelihood ratio) for incident adverse health events of the cognitive-prefrailty, cognitive frailty and MCR syndromes.
Status | Active, not recruiting |
Enrollment | 30000 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 85 Years |
Eligibility | Inclusion Criteria: 1. participants of the CLSA with baseline assessment (tracking and comprehensive assessment) and first 18-month follow-up assessment 2. age > 50 Exclusion Criteria: 1. no information which may directly or indirectly determine the occurrence of incident adverse health events (falls and related injuries, depression, functional decline, motoric cognitive risk syndrome, cognitive decline and dementia) 2. age < 50 and demented LCSA participants if they meet the following criteria: 1. History of dementia or Alzheimer's disease and/or use of anti-dementia drugs (i.e., Donepezil, Rivastigmine, Galentamine, regardless the dose taken) 2. Objective cognitive impairment (i.e., performance =2 SDs below the age-appropriate mean) in two cognitive domains (i.e., episodic memory and executive function) and abnormal scores on the ADL and IADL scales |
Country | Name | City | State |
---|---|---|---|
Canada | Jewish General Hospital | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Jewish General Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive-prefrailty | Defined as frailty and subjective cognitive impairment combined. Frailty (as proposed by Fried et al.) will be identified by the presence of = 3 of the 5 components: 1) unintentional weight loss, 2) Weakness (maximal grip strength); 3) Poor energy (answer of "no" to the question "Do you feel full of energy?" from the 15-item Geriatric Depression Scale); 4) Slowness as identified by an average walk speed, and 5) Low physical activity level. Participants with none of the above components will be considered to be vigorous and those with 1 or 2 components will be considered to be in a prefrail stage.
SCI will be defined using a proxy for subjective cognitive complaint (i.e. memory complaint) based on standardized memory loss question on the 15-item Geriatric Depression Scale (GDS; "Do you feel you have more problems with memory than most?"). |
1 day | |
Secondary | Falls | Number of falls | 12 months | |
Secondary | Depression | 10 items from the Center for Epidemiological Studies' Short Depression Scale (CES-D) score =10 | 1 day | |
Secondary | Activities daily living (ADL) | ADL score out of 6. Where a score of 3-5 is indicative of mild stages of neurocognitive disorders. | 1 day | |
Secondary | Motoric Cognitive Risk | Defined as having subjective cognitive complaint and slow walking speed (subjective cognitive complaint will be defined using the variable trouble concentrating or the self-reported memory problem, and slow walking speed will be defined as walking speed one standard deviation (SD) below the average of the cohort using the information of modules psychological health and physical health) | 1 day |
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